Introduction to EMA guideline on therapeutic equivalence studies of generic and reformulated products that are locally applied, locally acting in gastrointestinal tract
10.7501/j.issn.1674-6376.2017.08.003
- VernacularTitle:EMA用于胃肠道局部并作用于局部的仿制药或改剂型药的治疗等效性研究指导原则介绍
- Author:
lai Hui XIAO
1
Author Information
1. 国家食品药品监督管理总局药品审评中心
- Keywords:
EMA;
locally acting in the gastrointestinal tract;
generic;
equivalence;
guideline
- From:Drug Evaluation Research
2017;40(8):1050-1058
- CountryChina
- Language:Chinese
-
Abstract:
EMA announced Guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied,locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied,locally acting products containing known constituents (Draft) in March 2017,and proposed the general requirements for this equivalence study,introduced the requirements of equivalence studies for drugs acting different parts of the gastrointestinal tract,such as the mouth and/or throat,stomach,intestine and rectum,in detail,which focus on alternative methods of clinical trials-in vitro equivalence tests and PK bioequivalence studies.The guideline is introduced and it is expected to enlighten the trains of thought and methods for efficacy consistency evaluation of such generic and reformulated products in China.
